Single Use Nebulizer-Adjust-Air Entrain
FDA 510(k) K834077 · Airlife, Inc.
510(k) numberK834077
Submission
- Device name
- Single Use Nebulizer-Adjust-Air Entrain
- Applicant
- Airlife, Inc.
Mchenry, IL, US - Received
- November 25, 1983
- Decision date
- December 12, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAF – Nebulizer (Direct Patient Interface)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5630
- Specialty
- Anesthesiology
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| K251572 | eRapid with eTrack SystemCAF · Traditional | Pari Respiratory Equipment, Inc. | 12/19/2025SE |
| K251659 | Mesh Nebulizer (H6)CAF · Traditional | Qingdao Future Medical Technology Co., Ltd. | 11/14/2025SE |
| K244035 | Portable mesh nebulizer (JM821)CAF · Traditional | Shenzhen Jermei Medical Device Technology Co.… | 09/19/2025SE |
| K243468 | Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer…CAF · Traditional | Joytech Healthcare Co. , Ltd. | 07/02/2025SE |
| K250022 | HeroTracker SenseCAF · Traditional | Voluntis | 06/30/2025SE |
| K250583 | AdheResp Smart Breath-actuated Mesh NebulizerCAF · Traditional | Hcmed Innovations Co., Ltd. | 06/20/2025SE |
| K242354 | AllNEBCAF · Traditional | Enchant Tek Co. , Ltd. | 04/29/2025SE |
| K233553 | MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI AdapterCAF · Special | Thayer Medical Corporation | 06/18/2024SE |
| K232507 | Aerogen®Solo Nebulizer SystemCAF · Traditional | Aerogen, Ltd. | 05/10/2024SE |
More from Aerogen, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K834573 | Aqua TrapBYH · Traditional | 03/05/1984SE |
| K834570 | Volume Ventilator Circuit W/Water TrapBZO · Traditional | 03/05/1984SE |
| K833196 | Volume Ventilator Circuit-NebulizerCAI · Traditional | 11/03/1983SE |
| K833197 | Trach Swive/ConnectorBTR · Traditional | 10/28/1983SE |
| K832725 | Dual Dial Venturi Style MaskBYF · Traditional | 09/20/1983SE |
| K831246 | Whistler In-Line Pressure Release ValveCBP · Traditional | 07/26/1983SE |
| K830895 | Single Use Nebulizer, Adjust. Air-CAF · Traditional | 04/28/1983SE |
| K830896 | Humidifier, with or Without AdapterKFZ · Traditional | 04/18/1983SE |
| K821129 | Airlife Nebulizer HeaterCAF · Traditional | 05/18/1982SE |
| K821128 | Disposable Thermoplastic Rubber MouthBYP · Traditional | 05/13/1982SE |
Questions and answers
When was Single Use Nebulizer-Adjust-Air Entrain cleared by the FDA?
Single Use Nebulizer-Adjust-Air Entrain (K834077) received a 510(k) decision of Substantially Equivalent on December 12, 1983, 17 days after the submission was received.
What is the product code of K834077?
The FDA product code is CAF – Nebulizer (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5630.